Engineering Structures Jobs in Newport Beach, CA

***Candidates must be based in California, Maryland, or DC.***

ABOUT SEQUOIA CLIMATE FOUNDATION

Sequoia Climate Foundation is a climate philanthropy that believes in a world powered by clean energy, where all people are protected by policies that have averted the worst effects of climate change. We support bold strategies and efforts that will have both near-term impact and the greatest probability of long-term success. We believe that solving climate change requires the adoption of ambitious, evidence-based policy solutions that transform markets, advance clean technology, and lead to large‐scale change.

JOB SUMMARY

The Evidence and Learning Officer implements evidence and learning practices, providing actionable, evidence-based insights to grantmaking staff. They provide support in the development of theories of change, and review proposed strategies and grants to support high impact grantmaking. They work closely with grantmaking teams, providing training on key evidence and learning practices, as well as ongoing coaching and implementation support. They support strategic reflection practices with both grantmaking staff and grantees, using established methods and approaches. They work across multiple grantmaking portfolios, and are able to adapt their modes of engagement to meet the needs of grantmaking staff. Where necessary, they engage directly with grant recipients on evidence and learning related topics. They foster and embody a culture of organizational learning. The Research Officer will report to the Chief Evidence and Learning Officer, and collaborate closely with grantmaking staff across multiple organizations.

ESSENTIAL JOB FUNCTIONS & KEY OUTCOMES

• Collaborates with multiple grantmaking portfolios to support theory of change development and provide pragmatic reviews of proposed grantmaking (using established methods and protocols).
• Supports grantmaking teams to implement purpose-oriented reflection practices with grantees that support grant stewardship and ongoing learning.
• Supports implementation of structured processes for reflection and evidence-based briefings oriented toward distilling actionable insights that maximize climate impact.
• Collaborates with other Evidence and Learning staff to conduct purpose-driven, pragmatic quantitative analysis in support of philanthropic decision-making.
• Fosters and embodies a culture of iterative experimentation and learning internally and with partners.
• Manages multiple projects and timelines
• Performs other duties as required.

EDUCATION, EXPERIENCE & CREDENTIALS

• Advanced degree in policy, science, engineering, or mathematics required.
• A minimum of three years working in climate policy, climate philanthropy, or a related field is required.
• Demonstrated experience with synthesizing and translating technical content into actionable insights delivered verbally or writing or verbally required.
• Demonstrated experience with project management and coordination across a team required.
• Knowledge of learning and reflection practices preferred.

COMPETENCIES

• Integrity: Commitment to Sequoia Climate Foundation's mission and values.
• Inspirational Leadership: Demonstrated values-based, results-driven leadership.
• Collegiality: Strong work ethic and experience working collaboratively with a team.
• Efficiency/Initiative: Ability to learn quickly, juggle multiple tasks, prioritize effectively and meet deadlines.
• Quality/Compliance: Attention to detail and timelines.
• Analysis: Comfortable applying mathematical concepts, including calculus, statistics, and Bayesian probability.

WORKING CONDITIONS

This is largely a sedentary position that requires the ability to speak, hear, see, and lift small objects up to 15 lbs. Requires the ability to periodically travel locally, regionally, nationally, and internationally.

Sales Development Representative (Lead Manager / Acquisitions Specialist) - GG Homes | Irvine, CA

Are you a relentless communicator who thrives on the hunt? Do you get energized by making connections, qualifying opportunities, and knowing that your hustle is what fills the pipeline?

GG Homes is looking for a driven Sales Development Representative who's hungry to break into real estate acquisitions, loves being on the phone, and is ready to build serious income through performance. This is a role where your activity directly creates your opportunity—and your paycheck.

If you want a company that rewards your effort, invests in your growth, and makes winning feel like a celebration, let's talk.

Who We Are

GG Homes is a fast-growing real estate investment company and one of Southern California's leading cash buyers. We've built our success on delivering real solutions to homeowners while creating an environment where high performers can truly thrive.

Here's what makes us different: we believe in celebrating wins as much as we believe in working hard to achieve them. Whether it's team trips to Cabo after record months, Din Tai Fung lunches when we crush our goals, or sunset yacht dinners with the team, we make sure success feels rewarding—not just financially, but personally too.

The Role: Sales Development Representative (Lead Manager / Acquisitions Specialist)

This is a high-activity, phone-first role for communicators who are quick on their feet and relentless in their follow-through. As an SDR, you are the engine that powers GG Homes' acquisition pipeline. You'll be cold calling potential sellers, managing and qualifying inbound leads, and setting high-quality appointments for our Acquisitions Managers to close.

You won't be waiting for deals to come to you—you'll be creating them. Every call is a chance to build rapport, uncover motivation, and move a potential deal forward. The best SDRs treat their lead lists like a business, attack every dial with purpose, and take pride in the quality of the appointments they set.

What You'll Actually Do

• Cold call property owners from targeted lead lists to generate seller interest and uncover motivated leads
• Qualify inbound leads quickly and accurately, identifying the right sellers for our Acquisitions team
• Set high-quality, confirmed appointments for Acquisitions Managers—quality matters as much as quantity
• Build genuine rapport with sellers over the phone, earning trust and keeping conversations moving forward
• Follow up consistently with leads who aren't ready yet, turning "not now" into "let's meet"
• Manage your pipeline with precision in Salesforce, keeping every lead properly tracked and updated
• Hit daily, weekly, and monthly activity and appointment-setting targets
• Communicate clearly with Acquisitions Managers to ensure smooth handoffs and maximum close rates
• Strategize with leadership to refine your approach, improve conversion rates, and stay ahead of the market

Who You Are

Your DNA

• Natural communicator – you build trust fast, listen well, and know how to keep a conversation moving in the right direction
• Relentless and resilient – you make 100 calls, bounce back from 99 rejections, and come back the next day ready to go again
• Competitive and self-motivated – you track your own numbers and always try to beat yesterday's performance
• Organized and disciplined – you follow up on every lead, keep your CRM clean, and never let a deal fall through the cracks
• Hungry to grow – you want to learn the business, sharpen your skills, and eventually move into a closing role
• Coachable – you take feedback seriously, implement it fast, and improve continuously

Your Experience

• Background in phone-based sales, customer service, or lead generation—real estate, solar, insurance, financial services, home improvement, automotive, or similar industries preferred
• Demonstrated ability to hit call volume and conversion targets in a high-activity environment
• Experience handling objections and keeping prospects engaged even when they push back
• Comfortable working with CRM tools—Salesforce experience is a plus
• Strong verbal communication and active listening skills
• No real estate experience required—if you're driven, coachable, and ready to work, we'll train you on everything else

Compensation

We offer the best of both worlds: a solid base draw for stability, plus uncapped commission so your hard work translates directly into significant income.

• Base Salary Draw of $60,000 + Uncapped Commission Structure
• Realistic First-Year OTE: $100,000–$150,000 (for consistent performers)
• Top Performers Earn $400,000+ (we have team members doing it right now)
• No commission ceiling—your earning potential is completely in your control

This is a real opportunity to build financial freedom and fast-track your career in real estate.

Benefits & Culture

We work hard, but we also make sure it's worth it. Here's what you get when you join GG Homes:

• Flexible PTO – we trust you to manage your time and recharge when you need to
• Full Health Benefits – Medical, Dental, Vision, 401(k)
• Sales Competitions & Incentives – trips to Cabo, luxury dinners, cash prizes, and recognition for your wins
• Team Experiences – sunset yacht dinners, Padres games, escape rooms, deep sea fishing, sushi omakase, and more
• Beautiful Office Space – newly renovated with catered lunches, cold brew on tap, and premium snacks
• Homebuyers Program – we'll help you buy your own property
• Real Estate License Sponsorship – we'll cover the cost if you don't have one
• Ongoing Training & Development – learn from experienced closers and continuously sharpen your skills
• Clear Path to Promotion – top SDRs are first in line when Acquisitions Manager seats open up
• Supportive Team Environment – work with driven people who celebrate each other's wins and push each other to be better

GG Homes is an equal opportunity employer. We hire based on talent, character, and drive.

Interested in learning more? Apply with your resume and tell us why you're ready for this opportunity. We're looking for people who are serious about their success and ready to be part of something special.

Revelyst Adventure Sports, which consist of iconic brands like Fox Racing, Bell, Giro, Camelbak and Blackburn is looking for a Product Development Engineer (Contractor) to provide exceptional product and process expertise to bring innovative designs to market. The focus of this role is to develop quality, on-time, and cost-efficient products that are an accurate reflection of the Revelyst Adventure Sports brands as industry leaders.

The ideal Contractor will bring 4 year degree in Mechanical Engineering (BSME) or equivalent work experience, along with 3-5 years of consumer product developement or engineering experience. This individual must have enthusiastic, positive attitude and genuine passion for MX, MTB and Actiona Sports. Someone who is creative, forward‑thinking, and an energy giver. CAD proficiency (preferably SolidWorks), and experience in engineering injection‑molded components, working with plastics, and 3D modeling are essential to success.

Scope of Work

• Create the most innovative and market leading hardgoods products possible. Products will be evaluated for success using the following criteria: Innovation, function, fit, comfort, relevance to brand identity, technology utilization, quality, aesthetics, timely completion, manufacturability and realized margins.
• Closely work with Marketing and Design as a team to brainstorm innovative market leading ideas and concepts.
• Prepare and present project information to the Design and Marketing teams for review and decision making.
• Review and prioritize performance and style to properly incorporate them into products. Visualize performance and styling goals and create solutions to achieve them.
• Perform CAD work both internally and with Vendor as appropriate from concept through production.
• Working with Design and the vendor, create and evaluate functional prototypes to verify design intent.
• Create and maintain project documentation such as 3D CAD files, engineering drawings, spec sheets, bill of materials, project schedules, etc.
• Manage project scope and schedule to meet project deliverables and deadlines.
• Develop cost analysis of design proposals, assist with vendor quotations, track project costs to meet product design goals under the guidance of a manager.
• Deeply understand applicable safety and/or test standards and evaluate designs and solutions to meet them.
• Visit vendor’s manufacturing facilities to sample and commercialize intended product design. Study vendor’s development techniques, production processes and technological capabilities to enhance professional knowledge, further vendor relationship and assist in the innovation of product design/development
• Communicate internally and with international factories and vendors; both verbally and in writing critical and pertinent information that is needed in the development process.
• Research and evaluate new materials, manufacturing processes and trends that may be used for product innovation.
• Help build and maintain comprehensive materials and trims library.

Position Summary:

We are seeking a Human Factors Engineer who will be responsible for ensuring that medical devices are safe, intuitive, and effective for intended users by applying human factors and usability engineering principles throughout the product lifecycle. This role plans and conducts formative and summative usability studies, develops use-related risk analyses, and ensures compliance with FDA, IEC 62366, and other applicable regulatory standards. The Human Factors Engineer collaborates closely with design, clinical, regulatory, and quality teams to identify, mitigate, and validate use-related hazards, ultimately supporting safe and effective patient and clinician experiences.

This role will work to develop and follow industry best practices defining and documenting usability formative studies, qualitative assessments, summative usability studies and preparing the Human Factors engineering usability file for regulatory submission. This role will report to the Vice President of Product Design.

Key Responsibilities:

• Drive discovery research with mix method data collection techniques.
• Implement usability rating system and testing protocol.
• Work with marketing and clinical teams to create user personas, use specifications, and user groups based on target markets and regulatory testing requirements.
• Develop protocols for formative usability studies.
• Collaborate with recruiters, IRB, and consultants for validation studies.
• Moderate and conduct online and in person testing of usability studies, as well as focus groups, and interviews.
• Maintain detailed video documentation to follow and support note taking.
• Present findings to designers, engineers, and management team.
• Facilitate and document task analysis, use related risk analysis, and user interface specifications.
• Maintain traceability of critical statements and risk mitigations from observation to Instructions for Use and device training.
• Maintain awareness of and share industry trends and platform best practices in human factors, usability and digital experience on iOS, Android, and web.
• Define, test and ensure that accessibilities standards for each platform are met.
• Track cultural differences and risks for items, terminology, and features.

Required Qualifications:

• The candidate must be familiar with Design Controls (21 CFR Part 820 / ISO 13485) and have experience maintaining the Design History File (DHF).
• Demonstrated success working in startup, early-stage, or high-growth medical device environments.
• Proven ability to build process from the ground up and adapt them as the organization scales.
• Comfortable operating with ambiguity and making sound decisions with incomplete information.
• Strong bias toward action, ownership, and continuous improvement.
• Bachelors, Master’s or PhD in Human Factors, ergonomics or related field.
• 5+ years of experience in human factors engineering.
• Proven success running usability studies for medical devices.
• Proven work examples or projects running usability testing for mobile devices (iOS, or Android).
• Excellent communication, collaboration, presentation, and interpersonal skills.
• Strong process orientation and documentation abilities.
• Understanding of best practices including accessibility standards and human factor standards.

Referred Attributes:

• Entrepreneurial mindset with a passion for building systems that enable teams to do their best work.
• Excellent communication, collaboration, presentation, and interpersonal skills.
• Strong process orientation and documentation abilities.
• Understanding of best practices including accessibility standards and human factor standards.

Additional Information:

Approximately 25-30% travel may be required.

Physical requirements/Work Environment:

This position is located onsite in Irvine, CA.

This position primarily works in an office. It requires frequent sitting, standing and walking. This position requires sitting for long periods of time in front of a computer display or other digital devices. Daily use of a computer and other computing and digital devices is required. May require standing for extended periods when facilitating meetings, walking in the facilities. Some travel may be required so the ability to operate a motor vehicle and maintain a valid Driver’s license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Senior Counsel, Litigation & IP Strategy

You will lead litigation portfolio with a heavy focus on semiconductor technologies. You will bridge the gap between complex engineering concepts and compelling legal arguments, managing high-stakes disputes across the U.S., EU, and Asia-Pacific.

Key Responsibilities

• Strategic Oversight: Drive litigation strategy ,semiconductor-related IP, antitrust, trade secrets, and class action matters.

• Hands-on Execution: Draft pleadings and briefs for high-stakes cases and direct all phases of litigation from discovery through trial and appeal.

• Technical Translation: Collaborate with engineering teams to translate deep-tech architecture into winning legal positions.

• Global Risk Management: Manage outside counsel and litigation budgets while navigating regulatory inquiries and ITC Section 337 investigations.

• Executive Advisory: Partner with senior leadership to align legal risks with broader business and market dynamics.

Who You Are

• A Proven Expert: J.D. with 8+ years of litigation experience, including 3–5 years in a leadership capacity (In-House/NPE).

• Semi-Tech Savvy: Deep technical understanding of semiconductor design and memory systems.

• IP Veteran: Significant experience in patent litigation and inter partes review (IPR) proceedings before the PTAB.

• Strategic Thinker: You don't just manage cases; you proactively identify and mitigate risk before it hits the docket.

Preferred Qualifications

• In-house experience at a semiconductor/tech company or NPE

• Familiarity with SEPs (Standards-Essential Patents) and licensing negotiations.

• Advanced degree in Electrical Engineering is a major plus.

RED Digital Cinema, a Nikon Group company, is a leading manufacturer of professional digital cameras. RED's modular camera system and groundbreaking image quality are by far the best on the market today! RED continues to break ground with new products like the Z Mount KOMODO-X and V-RAPTOR-X. RED was used for major productions like The Queen's Gambit, The Social Dilemma, My Octopus Teacher, The Suicide Squad, The Morning Show, Russian Doll, Squid Game, Matrix, Red Notice, and Mank. In addition, RED has been selected as the camera of choice in 3 major productions, winning 2 Oscars and 3 Emmys in the cinematography category.

JOB DESCRIPTION

The Operations Project Manager plays an integral role in the day-to-day management and implementation of RED's products. They are meticulously organized, motivated, and performance driven person who can help the team complete projects in a rapidly changing environment. The ideal candidate is confident in communicating with others, be self-motivated, and have worked in collaborative team environment.

Responsibilities include but are not limited to:

• Coordinate departmental or cross-functional teams, focused on delivering new or upgrading existing products and capabilities.
• Monitor the project from initiation through delivery including planning and directing schedules and monitoring budget/spending.
• Organize cross-functional activities, ensuring completion of the project i.e., product on schedule and within budget constraints.
• Develop detailed project plans and manages all implementation processes including resource allocation, progress tracking, monitoring change control process, testing, documentation, training and on-time delivery.
• Partner with peers across all RED's Manufacturing and Quality teams, including Manufacturing Engineering, Manufacturing Test, Quality Assurance, Supply Chain, and Production.
• Direct responsibility for project management of key strategic operations initiatives within the Manufacturing and Operations organizations at RED. Strategic Initiatives include New Product Introduction (NPI) readiness, vendor onboarding, capacity planning, compliance and certification tracking and strategic sourcing.
• Identify and lead process improvement opportunities for the Manufacturing organization; includes Test, Quality and Production Groups.
• Collaborate on integrated master schedule and project plan with Engineering Project Management.
• Be an integral Team Member of the Project Management Office that spans Engineering and Manufacturing organizations and report to the Sr. Director, PMO at RED

Requirements:

• Bachelor's degree from an accredited university in a relevant field of study is preferred a minimum of 3 years of professional experience in a project manager role or equivalent role.
• Independent worker and thinker with a positive attitude and ability to work well with others in a team-oriented environment.
• Multi-task, meet deadlines, quickly process information and maintain confidential information with a dedication to ensuring quality of the product.
• Have sound knowledge of Manufacturing and Quality functions in a high technology environment.
• Have a proven track record of successful deployment of new product or process capability across Test, Quality and/or Production groups.
• Experience with project management software (e.g., Microsoft Project, Target Process, Pivatol Tracker, Jira, Basecamp),
• Project Management Certification e..g. PMP or PgMP preferred

We are seeking a Senior SoC/ASIC Physical Design Engineer to drive physical design activities to successful closure by collaborating closely with RTL and cross-functional engineering teams.

In this role, you will develop, refine, and implement cutting-edge flows and methodologies that optimize performance, power, and area (PPA), directly contributing to world class time to closure and tapeout with optimal team efficiency and resource allocation.

Responsibilities:

• Build modern physical design flows using EDA tool fusion and machine learning to optimize PPA, resources, and accelerate time-to-closure.
• Perform synthesis, floorplanning, PDN generation, place & route, timing, noise, verification, EM/IR checks, and signoff.
• Create and refine PD methodologies and automation scripts to streamline design and signoff processes.
• Partner with RTL, DFT, and ASIC teams to define architectural feasibility, timing/power/area targets, and design trade-offs.
• Apply a metrics-driven approach to resolve design and timing challenges and ensure predictable milestone delivery.
• Lead closure activities, including STA, noise analysis, logic equivalency, physical verification, and power integrity (EM/IR).

Qualifications:

• Bachelor’s in Electrical Engineering, Computer Engineering, or Computer Science .Master’s preferred
• At least 10 years of experience in ASIC/SoC physical design and flow development.
• Expertise in RTL-to-GDSII design flows, Synopsys EDA tools, and advanced PD methodologies like synthesis, place & route, STA, CDC, power analysis.
• Knowledge of FinFET/deep sub-micron CMOS, DFT methodologies like Scan, MBIST, LBIST and power/IR drop management.
• Strong ability to analyze design parameters and QoR metrics and implement advanced power optimization techniques such as SVS, DVFS, and SRAM split-rail architectures.
• Proficient in Python, Tcl, Perl, bash/csh, and automation scripting.
• Strong analytical and problem solving skills with proven ability to lead design closure and collaborate across teams.

The Senior Data Scientist will play a critical role in building the foundation of Boot Barn’s AI and Data Science division, with a focus on developing advanced machine learning and generative AI solutions. This position will lead the design and deployment of models that power data driven solutions to support cross-departmental products, and intelligent agentic systems.

Working closely with AI/ML and Data Engineers, this individual will ensure models are robust, well-designed, and ready to scale, while contributing to the establishment of data science best practices across the organization.

Essential Duties and Responsibilities

• Design, build, and deploy predictive and generative AI models to address high-impact applications such as personalization, forecasting, marketing automation, and conversational agents.
• Conduct exploratory data analysis, statistical modeling, causal inference, and A/B experimentation to uncover insights and validate model performance.
• Develop high-quality, modular Python code for model training and experimentation using libraries and frameworks such as pandas, numpy, scikit-learn, PyTorch, TensorFlow.
• Collaborate with AI/ML Engineers to productionize models through containerization, orchestration, and CI/CD pipelines.
• Collaborate with Data and AI/ML Engineers to establish RAG pipelines, vector databases, and agentic frameworks.
• Prototype and deploy generative AI applications such as content generation agents, knowledge assistants, and multimodal interfaces.
• Partner cross-functionally with Store Operations, Ecommerce, Marketing, Merchandise, Supply Chain and Real Estate to identify and prioritize high-impact AI opportunities.
• Contribute to data science best practices, model documentation, and the creation of reusable modeling frameworks.
• Translate complex model results into clear business insights for technical and non-technical audiences.
• Demonstrates high level of quality work, attendance and appearance.
• Demonstrates high degree of professionalism in communication, attitude and teamwork with customers, peers and management.
• Adhere to all local, federal and state laws in addition to Company policies, procedures, and practices.
• Performs any other duties that may be assigned by management.

Qualifications

• Bachelor's or Master’s degree in Statistics, Mathematics, Data Science, Engineering, Physics, Economics, or a related quantitative field.
• 3-5+ years of hands-on data science experience; proven track record in developing and deploying ML and generative AI models.
• Strong expertise in SQL, Python and core ML frameworks (scikit-learn, PyTorch, TensorFlow)
• Experience with LLMs, vector databases, and RAG pipelines
• Familiarity with MLOps workflows, containerization (Docker), and orchestration (Kubernetes) tools.
• Strong collaboration skills, with experience working closely with engineering and product teams.
• Retail and/or e-commerce experience preferred.

Competencies

• Ensure Effective Communication - Listens carefully and attentively to others' opinions and ideas. Communicates information clearly, concisely, and professionally.
• Establish Trust - Follows through on commitments. Is honest and direct with others. Promotes a culture of respect for, commitment to, and compliance with Company values, beliefs, and standards. Ensures the protection of confidential information.

Boot Barn Benefits & Additional Compensation Opportunities

• Competitive salary.
• Merchandise discount: 50% off of Exclusive Brands and 40% off of third-party brands.
• Paid Time Off plan for year-round Boot Barn Partners.**
• Medical, Dental, Vision and Life Insurance.**
• 401(k) plan with generous company matching.
• Flexible schedules and work/life balance.
• Opportunities for growth at every level – we are opening 50+ new stores each year.

**For eligible Boot Barn Partners

PAY RANGE: $125,000.00 - $150,000.00/yr*

*compensation varies based on geography, skills, experience, and tenure

Physical Demands

In general, the following physical demands are representative of those that must be met by a Partner to successfully perform the essential functions of this job. Reasonable accommodations may be made to allow differently abled individuals to perform the essential functions of the job.

• Standing, walking and squatting less than fifty percent of the work shift.
• Required to lift, move and carry up to 40 pounds.
• Ability to read, count and write to accurately complete all documentation and reports.
• Must be able to see, hear and speak in order to communicate with partners and customers.
• Specific vision abilities include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
• Manual dexterity required using hands to finger; handle, feel and type; reach with hands and arms.

[ ] Sedentary: Limited activity, no lifting, limited walking

[ X ] Light: Office work, some lifting, bending, stooping or kneeling, walking

[ ] Moderate: Mostly standing, walking, bending, frequent lifting

[ ] Arduous: Heavy lifting, bending, crawling, climbing

Work Environment

In general, the following conditions of the work environment are representative of those that a Partner encounters while performing the essential functions of this job. Reasonable accommodations may be made to allow differently abled individuals to perform the essential functions of the job within the environment.

• The workspace is clean, orderly, properly lighted and ventilated with the proper safety compliance.
• Noise levels are considered moderate.

Boot Barn, Inc. reserves the right to make exceptions to modify or eliminate this document or its content. This document supersedes all previous policies, procedures or guidelines pertaining to this subject.

Our core value of community bands us together in supportive and inclusive ways to drive our collective success. Boot Barn provides equal employment opportunity to all applicants and employees without regard to race, color, religion, sex, sexual orientation, age, national or ethnic origin, veteran or military status, disability, as well as any other protected status under the law.

Americans with Disabilities Act (ADA) - Boot Barn will provide reasonable accommodations (such as a qualified sign language interpreter or other personal assistance) with the application process upon your request as required by applicable laws. If you have a disability and require assistance in this application process, please visit your nearest Boot Barn Store or Distribution Center or reach out to Human Resources at 1-949-453-4400, Option 4.

California Privacy Notice

*Position only available on-site in Irvine, CA*

Job Summary:

We are seeking a highly experienced Clinical Studies Coordinator to lead and execute end-to-end clinical studies supporting FDA submissions (510(k)), pilot and feasibility studies, post-market clinical follow-up, and real-world evidence generation.

This role is hands-on, operational, and strategic. The ideal candidate has deep experience managing medical device and digital health clinical studies, working directly with FDA-facing documentation, IRBs, investigators, CROs, and internal regulatory, engineering, and product teams.

This position plays a critical role in de-risking regulatory submissions, ensuring GCP compliance, and translating clinical evidence into successful regulatory and commercial outcomes.

Key Responsibilities:

• Lead the planning, coordination, and execution of clinical studies, including:
• Pilot/feasibility studies
• IDE-exempt and IDE-supporting studies
• Pivotal and non-pivotal studies for FDA 510(k) submissions
• Post-market surveillance (PMS) and post-market clinical follow-up (PMCF)
• Real-world evidence (RWE) and usability studies
• Develop and manage study timelines, milestones, and deliverables
• Ensure studies are conducted in compliance with GCP,FDA regulations, ISO 14155 and other applicable standards.
• Prepare, review, and maintain clinical documentation for regulatory submissions, including:
• Clinical Study Plans (CSPs)
• Protocols and amendments
• Informed Consent Forms (ICFs)
• Statistical Analysis Plans (SAPs) (in collaboration with biostatistics)
• Clinical Study Reports (CSRs)
• Ensure audit-ready clinical documentation at all times

Other Responsibilities:

• Support subject recruitment and enrollment activities
• Conduct blood draws on study subjects.
• Process blood samples.
• Initiate IV's when the MD is unavailable.
• Supervise the maintenance of laboratory equipment, including calibration records.
• Maintain clinical staff training documentation.
• Perform other duties or special projects as requested.

Minimum Qualifications and Experience:

• 7 – 10 years of related experience or equivalent combination of education and experience.
• Excellent communication skills (both written and oral).
• Knowledge of clinical databases and data management systems
• Ability to be an integral part of an innovative, fast-paced product development team.
• Ability to manage multiple concurrent studies is essential
• LVN with IV training certificate or RN.

Preferred Qualifications:

• Bachelor's degree in Life Sciences, Biostatistics, Health Informatics, Biomedical Engineering
• Experience with clinical studies and interfacing with IRB.
• Clinical research certifications

Physical requirements/Work Environment:

This position primarily works in an office as well as laboratory environment. It requires frequent sitting, standing and walking. Work in a lab involves potential exposure to blood borne pathogens, as well as needles. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings, walking in the facilities, or processing tissue samples, blood, etc. Some local travel is necessary so the ability to operate a motor vehicle and maintain a valid Driver's license is required. Some travel to clinical sites might be required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

• This is hybrid in Irvine, CA
• Must be USC/GC - No sponsorship now or in the future.
• Compensation range: $166,982.45 - $184,559.55
• STI / Annual Bonus Target & Max: 10% / 20%

• Job Description:Manager Applications - Hire to Retire
• Purpose of the Job:The Manager – Oracle H2R will be a key leader in driving the success of client’s Oracle Fusion initiatives, with primary responsibility for the Human Capital Management (HCM) domain.
• This role will oversee the system architecture, implementation, operations support, and ongoing optimization of H2R processes, ensuring they are tightly aligned with both the Oracle Fusion platform and client’s business processes.
• The position also carries responsibility for managing platform customizations, extensions, and integrations to ensure seamless connectivity with other critical business functions, enabling growth, efficiency, and operational excellence.
• The role will manage and mentor a team of analysts and developers, building capabilities and fostering growth.
• The manager will drive the team and project deliveries towards success and act as both an architect and a hands-on functional expert, designing and delivering scalable, innovative solutions across HCM modules.
• This role will be a hands-on product techno-functional lead, creating system designs, such as and not limited to, defining HCM and related modules configurations, value sets, flex fields, setups, and other Oracle technical and functional system administration responsibilities for applications management.
• In addition, the Manager – Oracle H2R will serve as a product manager for HCM, shaping the product roadmap to align with client’s vision, industry best practices, and emerging technology advancements. By collaborating closely with business stakeholders and IT leaders, this role will translate business needs into robust, efficient, and user-friendly Oracle solutions, ensuring the HCM platform consistently delivers measurable value to the organization.

Major Duties and Responsibilities:

• Projects Delivery and Governance. Applications Techno Functional Leadership:Execute and deliver organizational initiatives and projects.
• Assess, plan, track, govern and deliver HCM and cross-functional initiatives on time and within budget, ensuring adherence to organizational standards and performance objectives.
• Own the full lifecycle of the HCM product, including implementation, enhancements, maintenance, architecture, operations, and performance management.
• Own, lead and be able to hands on configure HCM modules and related technical architectural system configurations. Like and not limited to:Configurations, Value sets, Flex fields. Attributes, Profiles, Workflow rules, Document types, Legal entities, Business units, Workforce structures, Plan and compensation structures, Security groups, Integration, setups, and other oracle system administration responsibilities.
• Lead, manage, and mentor a team of application analysts and developers involved in the design, configuration, development, and support of Oracle HCM applications.
• Establish governance and guidelines for HCM product management, including system design standards, security requirements, development practices, DevOps adherence, deployment planning, and operational support.

• Business and IT Engagement:Partner with business stakeholders to understand requirements, recommend solutions, and design strategic roadmaps for HCM systems and related functions.
• Ensure alignment of the HCM product roadmap with the broader organizational IT and business vision.
• Communicate status, challenges, risks, and successes effectively to senior leadership, business users, and key stakeholders.
• Coaching and Mentoring:Define performance standards for the team, conduct periodic evaluations, and provide constructive feedback.
• Mentor and coach team members to support professional growth, aligning individual aspirations with organizational needs.
• Develop and deliver training programs to strengthen technical and functional expertise, teamwork, and continuous learning within the team.
• Platform Operations and Optimization:Oversee the entire application lifecycle for Oracle HCM and related cross-functional systems, ensuring reliability, scalability, and security.
• Review and evaluate SaaS product updates. Validate, test and deploy periodic releases and any required oracle patches.
• Assess impacts, and implement new features and fixes to support evolving business requirements.
• Stay current with emerging technologies, recommending and implementing improvements that optimize platform performance and align with industry best practices.
• Documentation, Compliance and Data Governance:Ensure creation, maintenance, and accuracy of all relevant HCM documentation, including architecture diagrams, technical designs, workflows, and training materials.
• Able to use and adapt various project implementation methodologies and tools, like and not limited to - Agile, SAFe, CI/CD, AIM, and Jira and documenting the designs, requirements, architectures in respective formats - like user stories, lucid charts, confluence pages, build deployments etc.,
• Enforce data governance policies and ensure compliance with organizational, regulatory, security, and privacy standards.
• Oversee adherence to change management, compliance frameworks, and corporate IT policies across the HCM platform.
• Education and Experience:Education: Bachelor’s degree in Computer Science, Information Technology, Human Resources, or a related field (required).
• Implementation Experience: Proven track record with Oracle Fusion implementations, including at least three end-to-end projects and two full-cycle implementations covering H2R process areas (required).
• ERP Knowledge: 8 plus years of experience with Oracle ERP products, with strong understanding of platform functionality, cross-functional integrations, and hands-on expertise in H2R process cycles. (required)
• Fusion Experience: 3 plus years of experience specifically with the Oracle Fusion platform, including functional and technical capabilities. (preferred - if no fusion experience, EBS R12 is required)
• Leadership: 3 plus years managing teams in an ERP environment (required), preferably within Oracle Fusion HCM functions.
• Ability to travel domestically up to 2%.
• Technical Skills: Experience with PlSql, OCI, VBCS, Redwood UI (preferred).
• Certifications:Oracle Cloud Infrastructure Foundations (preferred)
• Oracle Fusion Cloud Applications HCM Process Essential Certified. (preferred)
• Oracle Global Human Resources Cloud Implementation Professional. (preferred)
• People and Product management expertise, and related certifications. (preferred)

Knowledge and Skill Level:

• Oracle Fusion HCM Expertise:Advanced, hands-on experience in Oracle Fusion implementation, development, and maintenance.
• Advanced, hands-on experience in techno functional configurations of the platform - like not limited to as listed below:Configurations, Value sets, Flex fields, Attributes, Profiles, Workflow rules, Document types, Legal entities, Business units, Workforce structures, Plan configurations, Compensation structures, Security groups, Integrations, Setups, and other oracle system administration responsibilities.
• Deep functional knowledge of the Hire-to-Retire (H2R) process oracle setups and associated modules and be able configure them ground up, including and not limited to:Recruiting and Onboarding
• Workforce Management
• Compensation and Benefits
• Talent and Performance Management
• Employee Self-Service
• Retirement and Separation
• Technical Skills:Proficiency in Oracle platform extensions, modifications, and customizations (ex: PL/SQL, VBCS, Redwood UI. etc.).
• Solid understanding of data architectures, management, reporting, and analytics, including OTBI, BI Publisher, and FBDI.
• Experience with systems integration using Oracle Integration Cloud (OIC), SOAP/REST APIs, with exposure to MuleSoft preferred.
• Implementation Methodologies:Strong expertise in AIM methodology, OUM, and SDLC practices.
• Skilled in applying best practices, hybrid models, and Agile/SAFe frameworks to deliver projects effectively.
• Demonstrated success in leading and delivering full lifecycle Fusion projects — from requirements gathering to deployment, adoption, and ongoing optimization.
• Able to use, and apply tools like Jira, Visio, Lucid, Confluence to create user stories, architectures, vision boards, technical and functional designs etc.
• Program and Vendor Management:Track record of leading cross-functional teams, consultants, and SI partners to deliver successful outcomes.
• Experience in managing vendors, evaluating new products and platforms, and overseeing solution adoption.
• Skilled in drafting and managing RFPs, SOWs, and contracts; facilitating vendor assessments and partner selection.
• Leadership, Communication and Continuous Learning:Strong leadership and people manager skills with proven ability to mentor, coach, and scale teams, particularly in Oracle Fusion HCM modules.
• Effective collaborator, able to influence stakeholders and drive consensus across business and IT teams.
• Excellent communication skills, both written and verbal, with comfort engaging executives, business partners, and technical staff.
• Ability to stay ahead of Oracle Fusion and HCM innovations, proactively piloting and adopting new features.
• Strategic mindset with a focus on aligning platform capabilities to evolving business needs.
• Passion for continuous improvement and learning, with a current focus on emerging technologies within enterprise IT.